FDA Issues Final Rule on Nutrient Content Claims for Omega-3 Fatty Acids

The U.S. Food and Drug Administration (FDA) has announced a final rule prohibiting statements on food product labels, including dietary supplements, that claim products are “high in,” “rich in,” or an “excellent source of” docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) as well as similar claims for alpha-linolenic acid (ALA). The rule finalizes a proposed rule the agency published in 2007 without any substantive changes.

Under the U.S. Federal Food, Drug, and Cosmetic Act (the Act), nutrient-content claims such as “high in” are allowed only for nutrients for which a reference level for the claim has been set, or, in some situations, if the requirements of the Act have been met, such nutrient levels can be based on authoritative statements published by certain types of scientific bodies, such as the Institute of Medicine of the National Academies (IOM).

FDA apparently received notifications in 2004 and 2005 asserting that IOM had issued authoritative statements that identified such nutrient levels for DHA, EPA and ALA. The agency reports, however, that multiple notifications identified multiple, and sometimes conflicting, nutrient levels for the omega-3 fatty acids, leading FDA to determine that none of the claims met the Act’s requirements.

Stakeholder comments on the agency’s analysis of the proposed rule’s impact suggested that hundreds of product categories, including seafood, yogurt, cheese, meat, eggs, milk, juice, bread, and baby food would be affected by the rule and labeling changes would be costly and place an unfair burden on small businesses. Allowing for a transition period, FDA noted that the rule will take effect January 1, 2016, and manufacturers will have up to one year to comply and change food and supplement labels accordingly. See CFSAN Constituent Update, April 25, 2014.

Issue 522